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Transversus Abdominis Plane Block In Children

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ClinicalTrials.gov Identifier: NCT02990975
Recruitment Status : Unknown
Verified December 2016 by ILKE KUPELI, Erzincan University.
Recruitment status was:  Active, not recruiting
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
ILKE KUPELI, Erzincan University

Tracking Information
First Submitted Date  ICMJE December 4, 2016
First Posted Date  ICMJE December 13, 2016
Last Update Posted Date December 13, 2016
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
the amount of anesthetic drug which was used [ Time Frame: two hour ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
Postoperative visual analogue scale [ Time Frame: one day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transversus Abdominis Plane Block In Children
Official Title  ICMJE Effect of Ultrasonography Guided Transversus Abdominis Plane Block to Intraoperative Anesthesia in Children: Randomized Controlled Study
Brief Summary Aim of this study; Intra-operative anesthesia and analgesia effects of Transversus Abdominis Plane Block supported by ketamine sedation only.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Intra-operative Anesthesia
Intervention  ICMJE Drug: ketamine
Study Arms  ICMJE
  • Active Comparator: block and ketamine
    Transversus Abdominis Plane block after ketamine atropine induction and continued with ketamine only in anesthesia
    Intervention: Drug: ketamine
  • Active Comparator: ketamine atropine; laryngeal mask
    After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane MAC and oxygen / air mixture and applied Transversus Abdominis Plane block.
    Intervention: Drug: ketamine
  • Active Comparator: control group
    After ketamine atropine induction, a laryngeal mask was inserted and anesthesia administration was continued with 2 sevoflurane MAC and oxygen / air mixture and Non-block, postoperative analgesia with paracetamol IV
    Intervention: Drug: ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 8, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ASA I-II
  • To undergo elective lower abdominal surgery
  • between 2-6 years old

Exclusion Criteria:

  • Patients with psychiatric disease
  • Patients whose weight is more than 40 kg
  • Patients with cardiac-pulmonary-neurological disease
  • Patients with bleeding disorder
  • Patients with infection or scar on the injection area
  • Patients with known allergies to local anesthetics
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02990975
Other Study ID Numbers  ICMJE ERZINCAN UNIVERSITY 7
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ILKE KUPELI, Erzincan University
Study Sponsor  ICMJE Erzincan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: ilke kupeli Erzincan University
PRS Account Erzincan University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP